EP0732950B1 - Injection device having polyparaxylylene coated container and needle - Google Patents

Injection device having polyparaxylylene coated container and needle Download PDF

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Publication number
EP0732950B1
EP0732950B1 EP95904071A EP95904071A EP0732950B1 EP 0732950 B1 EP0732950 B1 EP 0732950B1 EP 95904071 A EP95904071 A EP 95904071A EP 95904071 A EP95904071 A EP 95904071A EP 0732950 B1 EP0732950 B1 EP 0732950B1
Authority
EP
European Patent Office
Prior art keywords
cartridge
needle
medicament
plunger
polyparaxylylene
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP95904071A
Other languages
German (de)
French (fr)
Other versions
EP0732950A4 (en
EP0732950A1 (en
Inventor
C. Michael Mesa
M. Lawrence Dalling
Sandra A. Lowery
O. Napoleon Monroe
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Meridian Medical Technologies Inc
Original Assignee
Meridian Medical Technologies Inc
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Filing date
Publication date
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Publication of EP0732950A1 publication Critical patent/EP0732950A1/en
Publication of EP0732950A4 publication Critical patent/EP0732950A4/en
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Publication of EP0732950B1 publication Critical patent/EP0732950B1/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • A61M2005/3131Syringe barrels specially adapted for improving sealing or sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels

Definitions

  • This invention relates to the treatment of patients by medicament injection and more particularly to an improvement in injection devices such as automatic injectors and syringes.
  • an automatic injector is a device for enabling an individual to self-administer, or administer to another, a dosage of a liquid medicament.
  • An advantage of automatic injectors is that they contain a measured dosage of a liquid medicament in a sealed sterile condition capable of storage in such condition for an extensive period of non-use, during which period immediate injection of the stored dosage may be accomplished at any time under severe emergency conditions.
  • Another advantage of automatic injectors is that the administration of the self-contained dosage of liquid medicament is accomplished without the necessity of the user initially seeing the hypodermic needle through which the liquid medicament is injected or of manually penetrating such a visible needle into the user's or another person's tissue.
  • an automatic injector includes a releasable energy source, typically a stressed spring assembly.
  • a spring assembly typically includes a stressed spring, a mechanism for releasably retaining the spring in a stressed storage position, and a releasing mechanism for releasing the releasable mechanism in response to a predetermined actuating procedure.
  • automatic injectors are particularly suited for use under emergency conditions.
  • many tens of millions of such automatic injectors have been manufactured and sold containing nerve gas antidotes for use under emergency chemical warfare conditions.
  • Typical units which have been utilized for this purpose are disclosed in U.S. Patent Nos. 2,832,339, 3,882,863, and 4,031,893.
  • units of this type have been manufactured and used in administering anti-arrhythmic medicaments under emergency conditions relating to heart attack medical situations.
  • the use of an auto injector has also been proposed to provide other medicaments useful in treating heart attack symptoms such as clot selective thrombolytic agents (for example, tPA) and related medicaments. See, for example, U.S. Patent Nos.
  • the auto-injector is specifically structured so that in its normal operation, the needle extends into the muscle tissue of the user and a specified amount of liquid medicament stored in a cartridge within the injector is injected into the tissue of the user.
  • injectors Since these injectors are to be used most often in emergency situations, it can be appreciated that such injectors must be very reliable in its administration of a medicament. These injectors must operate correctly even after being stored for an extensive period of time. At the same time, these injectors should be small enough and light enough to enable the user, who may be subject to an emergency condition, to easily carry the injector on his or her person at all times. It can also be appreciated that the injectors must be durable and be able to withstand shock from impact which can occur when the injector is continuously kept on a user's person, such as in the user's pocket or the like. This is especially the case when such injectors are carried by soldiers during times of warfare.
  • the cartridge for containing the medicament in most automatic injectors has been made from glass. This is primarily due to the fact that glass is highly stable and largely non-reactive with contained medicaments even after long periods of contact.
  • the filling machines are limited in the speed at which such cartridges can be filled and then closed (with an elastic plunger or the like) due to the somewhat delicate nature of the glass material. Even with slower filling and assembly speeds, such glass cartridges are nevertheless subject to breakage.
  • a further situation in which the glass cartridge may break is where the spring assembly provided for forcing an expelling plunger through the cartridge does so in an erratic fashion. Specifically, any bending of the spring may cause the spring to impact against the inner glass surface of the cartridge and cause breakage thereof.
  • the mere compression of medicament within the glass cartridge during compressive expulsion of such medicament with the plunger may be sufficient to cause breakage of the cartridge if proper precautions are not taken. While the above-mentioned scenarios are extremely infrequent and unlikely, it can be appreciated that the emergency use of these injectors requires that such scenarios be limited to the fullest extent feasible.
  • an automatic injector which has a cartridge made from a substance which is more durable, workable and/or less expensive than glass.
  • metal has been used.
  • an automatic injector having a stainless steel cartridge is manufactured by the assignee of the present invention and sold under the registered trademark ATROPEN®. While it has also been determined that plastic might be another viable alternative, it has heretofore not been widely practical as will be discussed later.
  • Metal and plastic both have several advantages over glass in that it can be made both thinner and lighter while at the same time stronger than glass. Thus, the automatic injector can become more durable and more reliable.
  • metal cartridges may react with certain (if not all) medicaments (for example, lidocaine) and thereby contaminate such medicaments.
  • plastic With respect to plastic, a problem exists in that plastic is not completely impervious to moisture and oxygen, and therefore not well suited to store a medicament for extended periods.
  • plastic While it may also be desirable to use plastic in the main body of a prefilled conventional syringe (in addition to use in automatic injectors), such use has also been rather impractical for many types of medicines.
  • a plunger provided therein for expelling medicament therefrom has a tendency to adhere to the side walls thereof during extended periods of non-use.
  • a resilient plunger sitting in contact with a metallic cartridge for a significant period of time may eventually become slightly adhered to the metallic surface of the cartridge.
  • the stressed spring contained within an auto-injector weakens in strength after remaining in compression for extended periods.
  • the medicament may not be dispensed at all or will be dispensed more slowly than what might otherwise be possible. This is significant since the time interval which lapses before a full dosage of medicament is dispensed may be important to the remedial results which are obtained by administration of the medicament.
  • the present invention contemplates providing a metallic cartridge having a polyparaxylylene coating applied to at least an inner surface thereof.
  • a metallic cartridge having a polyparaxylylene coating applied to at least an inner surface thereof.
  • Polyparaxylylene has been found to be useful in coating various materials.
  • U.S. Patent No. 5,000,994 it is disclosed that it is useful to coat rubber closures in order to reduce ion extraction from the rubber material into the medicament and to reduce the coefficient of friction of the surface of such rubber closures to facilitate the manufacture thereof as such rubber components may become hung up on one another or on transfer equipment.
  • This disclosure is not concerned with using polyparaxylylene to coat a non-glass container to provide a more economic, reliable, and durable container.
  • application of polyparaxylylene to the plunger in an automatic injector may harden the elastic surface of the plunger and may have a detrimental effect on the seal between the plunger and cartridge.
  • an automatic injector comprising a housing having a metallic cartridge contained therein.
  • the cartridge has at least an inner surface thereof provided with a polyparaxylylene coating.
  • a charge of medicament is contained within the metallic cartridge and in communication with the polyparaxylylene coating, which reduces the coefficient of friction of the inner surface of the cartridge and prevents metallic ions from being extracted from the cartridge and into the medicament.
  • a plunger is normally disposed in a generally rearward end of the metallic cartridge, and is movable through the cartridge toward a generally forward end thereof in response to a predetermined actuating procedure. The movable plunger rearwardly confines the medicament within the metallic cartridge and is in slidable sealed relation with the polyparaxylylene coating provided on the metallic cartridge.
  • the polyparaxylylene coating reduces the tendency of the plunger to adhere to the inner surface and reduces the time required for the plunger to travel from the generally rearward end to the generally forward end of the metallic cartridge.
  • a needle is normally disposed within the housing and is projectable from a forward end of the housing and communicable with the medicament so that movement of the plunger through the cartridge forces the medicament through the needle and into the tissue of a user in response to the predetermined actuating procedure.
  • a releasable energy source is releasable in response to the predetermined actuating procedure to project the needle and slidingly drive the plunger through the metallic sealed relation to expel the medicament through the needle and into the tissue of the user.
  • certain of the aforementioned automatic injectors are provided with a metallic needle that is normally stored in contact with a medicament.
  • Such type of injectors are disclosed in our previously granted U.S. Patent Nos. 4,484,910, 5,085,642, and 5,092,843.
  • An advantage of such injectors is that they have a shorter axial length than other type of injectors that have the needle normally stored in a separately provided chamber disposed forwardly of the medicament (e.g. see our previously granted U.S. Patent No. 5,102,393).
  • metal cartridges may react with certain medicaments, such as lidocaine, and thereby contaminate such medicaments.
  • an automatic injector which comprises a housing, a cartridge contained within the housing, a charge of medicament contained in the cartridge, and a needle normally disposed within the cartridge so as to be in communication with the medicament.
  • the needle is provided with a polyparaxylylene coating for preventing ions from being extracted from the needle into the medicament.
  • the needle is projectable from a forward end of the housing, while a plunger is normally disposed in a generally rearward end of the cartridge and movable through the cartridge in response to a predetermined actuating procedure so as to force the medicament through the needle and into the flesh of an individual.
  • a releasable energy source is releasable in response to the predetermined actuating procedure to project the needle from the forward end of the housing and drive the plunger through the cartridge to expel the medicament through the needle and into the flesh of the individual.
  • US-A-4,225,647 discloses the vapour phase coating of polyparaxylylene on surfaces of various objects which are quite different from the surface and object which are coated with polyparaxylylene with accordance with the disclosure and claims of the present invention.
  • the invention relates to an automatic injector as claimed in claims 1 and 10.
  • FIGURE 1 is a longitudinal sectional view, with a portion thereof shown enlarged, of an automatic injector embodying the principles of the present invention.
  • An automatic injector generally indicated at 10 embodies the principles of the present invention.
  • the injector 10 includes a tubular housing 12, a medicament injecting assembly, generally indicated at 14, within the forward end portion of the housing assembly 12, and a releasable energy source which is releasable in response to a predetermined actuating procedure as will be described more fully later.
  • the releasable energy source can be any type of assembly which effectuates an injection operation (e.g. a compressed gas assembly as disclosed in our U.S. Patent No. 4,518,384)
  • the releasable energy source be a stressed spring assembly, as generally indicated at 16.
  • the stressed spring assembly is disposed within the rearward end portion of the housing assembly 12 in operative relation with the medicament injecting assembly 14.
  • a releasable end safety cap 18 positioned at the rear of the housing assembly 12 is in operative relation with the stressed spring assembly 16.
  • the housing assembly 12, medicament injecting assembly 14, and stress spring assembly 16 are generally constructed in accordance with the teachings of U.S. Patent No. 2,832,339. As shown in FIGURE 1, the housing assembly includes a cylindrical outer housing member 20 having a centrally apertured cylindrical rear wall portion 22 of reduced diameter on which the safety end cap 18 is mounted.
  • the housing assembly 12 also includes an inner cylindrical housing member 24 within the housing member 20 within which is mounted the medicament injecting assembly 14 and the stressed spring assembly 16.
  • the forward portion of the inner housing member 24 is formed with a counterbore for receiving therein a cylindrical dosage container or cartridge 26.
  • This cartridge is made of a metallic material. The preferred metallic materials are stainless steel and aluminium.
  • Cartridge 26 has an inner surface 27 which is coated with a continuous poly (p-xylylene) or polyparaxylylene coating 29 (see, exploded portion of FIGURE 1).
  • This coating is preferably provided to the cartridge or container by a process in which the polymer is deposited onto the cartridge from the vapor phase in a manner which resembles vacuum metallization. Unlike vacuum metallization, however, which is conducted at pressures of 10 -5 torr or below, the polyparaxylylene coating is formed at around 0.1 torr. Such coating is also known as Parylene and is provided by Specialty Coating Systems, Inc. of Indianapolis, IN. As a result of the procedure in which the polyparaxylylene is applied to the cartridge 26, it can be appreciated that the outer surface of the cartridge may also be coated. However, steps could be taken to prevent the coating of the outer surface if so desired.
  • Polyparaxylylene has several useful properties, such as low permeability to oxygen and moisture, low coefficient of friction, high durability at high temperatures (expected lifetime of approximately ten years at 100 degrees Celsius), high resistance to impact at cryogenic temperatures, high chemical resistance, and excellent adhesion to the surface it is provided to.
  • the polyparaxylylene should have a thickness of between about 0,00025 mm to 0.0025 mm (.00001 to .001 inches).
  • the coating preferably ranges from 0.0013 mm to 0.0076 mm (.00005 to .0003 inches), and in the case of plastic, it is preferred that the coating range from 0,0017 mm to 0,013 mm (.00007 to .0005 inches) in thickness.
  • the polyparaxylylene coating in the present invention has a preferred thickness ranging between a minimal level of acceptable intended functionality and a maximum level beyond which any added functionality which might be obtained from additional thickness is not worth the added cost of material required to obtain such increased thickness.
  • the forward end of the container or cartridge 26 is closed by a stopper or plug 28 of suitable rubber or plastic material.
  • Plug 28 is retained in closing relation with the forward end of the cartridge 26 by a housing end cap member 30 of molded plastic material.
  • the cap is retained on the inner housing member 24 by inter-engagement of a pair of ridges 32 formed on the exterior periphery of the tubular member 24 with an annular groove 34 formed on the interior periphery of the cap member 30.
  • the rearward end of the cartridge 26 is closed by a plunger 36 which is slidably, sealingly engaged with the polyparaxylylene coating 29 at the rearward end of the cartridge so as to enclose within the cartridge a dosage 38 of a liquid medicament.
  • the polyparaxylylene coating 29 reduces the coefficient of friction of the inner surface 27 of the cartridge 26 and eases movement of the plunger when the plunger is forced forwardly through cartridge 26 (towards the right in FIGURE 1).
  • plunger 36 is coated with a substance which prevents extraction of metallic ions therefrom into the medicament 38 and further helps the plunger move through cartridge 26 during an injection.
  • Such coating must be made of a material which is medicament compatible. While the coating can be polyparaxylylene, it is preferably made of some other medicament compatible substance as it has been found that polyparaxylylene may harden the outer surface of the elastic plunger to the extent that the plunger is unable to make an effective seal with the cartridge.
  • a hypodermic needle 40 is disposed within the cartridge 26.
  • needle 40 is normally stored in contact with the medicament 38.
  • needle 40 can be disposed in a separate chamber (either evacuated or filled with a preferably inert gas) forwardly of the medicament 38 (for example, see our U.S. Patents No. 5,085,642 and 5,102,393), so long as the needle is somehow communicable with the medicament in a manner which permits the medicament to travel through the needle and into the flesh of an individual.
  • the needle can also be disposed in contact with one of two medicaments, which are normally stored separately within the injector and then either mixed within the injector prior to an injection (e.g.
  • the hypodermic needle 40 is preferably made from stainless steel. In the instance in which the needle is stored in contact with the medicament, as described above, it is preferred that the needle be coated with a layer of polyparaxylylene to prevent ions from being extracted from the needle and into the medicament. Both the external surface of the needle (visible in Figure 1) and the internal surface (defining the inner path through the needle) can be coated.
  • the needle 40 has its pointed end disposed within a recess formed in the plug 28.
  • a disc 42 of plastic is disposed within the forward end of the cartridge 26 in surrounding sealed relation with the hypodermic needle 40 and in abutting engagement with the plug 28. The disc serves to releasably hold the needle in its storage position to provide peripheral centering therefor during the dosage injecting stroke of the plunger 36.
  • the rearward end of the hypodermic needle 40 is enlarged for engagement by the plunger and has a slot 44 formed in its periphery adjacent the enlarged end for communicating the dosage 38 with the hollow interior of the hypodermic needle 40 when the plunger 36 is in engagement therewith.
  • the inner housing member 24 is mounted within the outer housing member 20 for limited reciprocating movement as determined by a pair of ridges 46 formed on the exterior periphery of the tubular inner housing member 24 at a position spaced rearwardly from the pair of ridges 32.
  • the pair of ridges 46 is adapted to engage with an elongated annular groove 48 formed on the interior periphery of the outer housing member 20.
  • the stressed spring assembly 16 includes a normally compressed but releasable coil spring 52 and an elongated collet member 50 made up of two interfitted stampings.
  • the collet member is disposed within the rearward portion of the housing member 24 and has its forward end disposed in abutment with the plunger 36.
  • the forward end of the collet member 50 is also exteriorly configured to engage the forward end of the stressed coil spring 52 which surrounds the central portion of the elongated collet member 50 within the inner housing member 24 and has its rearward end engaged with an apertured end wall formed integrally on the rearward end of the inner housing member 24.
  • the rearward ends of the stampings of the elongated collet member 50 are split to provide four laterally movable spring fingers 56, the rearward extremities of which are formed with rearwardly and outwardly facing cam releasing surfaces 58.
  • Extending inwardly from the forward end of each cam surface 58 is a locking shoulder 60 adapted to engage a locking ring 62 seated on the rear surface of the centrally apertured rear wall 54.
  • the forward portion of the apertured cylindrical wall portion 22 is formed with a frusto-conical surface 64 which is disposed in engagement with the cam surfaces 58 so as to effect a laterally inward movement of the spring fingers toward one another to disengage locking shoulders 60 from locking ring 62 in response to a relative forward actuating movement of the outer housing member 20 with respect to the inner housing member 24.
  • releasable end cap 18 is removed from the injector 10. This removal is accomplished simply by gripping the exterior periphery of the end cap 18 and moving it rearwardly while gripping and holding the outer housing member 20.
  • the removal of the cap member 18 carries with it a safety pin portion 70.
  • the safety pin portion 70 removed from its safety position which normally prevents the laterally inward movement of the spring fingers 56, the user can now complete the operation by moving the forward cap member 30 into contact with the tissue of a person to be injected.
  • cam surfaces 64 thereof are moved forwardly with respect to the locking ring 62.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

BACKGROUND OF THE INVENTION
This invention relates to the treatment of patients by medicament injection and more particularly to an improvement in injection devices such as automatic injectors and syringes.
Automatic injectors are well known. Basically, an automatic injector is a device for enabling an individual to self-administer, or administer to another, a dosage of a liquid medicament. An advantage of automatic injectors is that they contain a measured dosage of a liquid medicament in a sealed sterile condition capable of storage in such condition for an extensive period of non-use, during which period immediate injection of the stored dosage may be accomplished at any time under severe emergency conditions. Another advantage of automatic injectors is that the administration of the self-contained dosage of liquid medicament is accomplished without the necessity of the user initially seeing the hypodermic needle through which the liquid medicament is injected or of manually penetrating such a visible needle into the user's or another person's tissue. Instead, an automatic injector includes a releasable energy source, typically a stressed spring assembly. A spring assembly typically includes a stressed spring, a mechanism for releasably retaining the spring in a stressed storage position, and a releasing mechanism for releasing the releasable mechanism in response to a predetermined actuating procedure.
As stated above, automatic injectors are particularly suited for use under emergency conditions. For example, many tens of millions of such automatic injectors have been manufactured and sold containing nerve gas antidotes for use under emergency chemical warfare conditions. Typical units which have been utilized for this purpose are disclosed in U.S. Patent Nos. 2,832,339, 3,882,863, and 4,031,893. In addition, units of this type have been manufactured and used in administering anti-arrhythmic medicaments under emergency conditions relating to heart attack medical situations. The use of an auto injector has also been proposed to provide other medicaments useful in treating heart attack symptoms such as clot selective thrombolytic agents (for example, tPA) and related medicaments. See, for example, U.S. Patent Nos. 4,689,042, 4,755,169, and 4,795,433. Finally, automatic injectors have been marketed containing a dosage of epinephrine as an antidote for counteracting severe allergic reactions, as for example, to bee stings, and the like.
In all of these instances, the auto-injector is specifically structured so that in its normal operation, the needle extends into the muscle tissue of the user and a specified amount of liquid medicament stored in a cartridge within the injector is injected into the tissue of the user.
Since these injectors are to be used most often in emergency situations, it can be appreciated that such injectors must be very reliable in its administration of a medicament. These injectors must operate correctly even after being stored for an extensive period of time. At the same time, these injectors should be small enough and light enough to enable the user, who may be subject to an emergency condition, to easily carry the injector on his or her person at all times. It can also be appreciated that the injectors must be durable and be able to withstand shock from impact which can occur when the injector is continuously kept on a user's person, such as in the user's pocket or the like. This is especially the case when such injectors are carried by soldiers during times of warfare.
Heretofore, the cartridge for containing the medicament in most automatic injectors has been made from glass. This is primarily due to the fact that glass is highly stable and largely non-reactive with contained medicaments even after long periods of contact.
However, several problems exist with automatic injectors having glass cartridges. One major problem is that such cartridges must be specially made or uniquely protected in order to reduce the likelihood of breakage. For example, the cartridge might be made thicker and thus heavier. As a result, the automatic injector as a whole becomes somewhat larger, more costly, more complicated or all of the above. In addition, the injector becomes an inconvenience to an individual who must carry the injector at all times. Furthermore, even with making these provisions, the cartridge nevertheless remains subject to breakage. Such breakage can occur for numerous reasons. For example, the automatic injector may be dropped or otherwise exposed to severe mechanical shock. Another instance in which such breakage may occur is during filling of the cartridge with medicament. Oftentimes, the filling machines are limited in the speed at which such cartridges can be filled and then closed (with an elastic plunger or the like) due to the somewhat delicate nature of the glass material. Even with slower filling and assembly speeds, such glass cartridges are nevertheless subject to breakage. A further situation in which the glass cartridge may break is where the spring assembly provided for forcing an expelling plunger through the cartridge does so in an erratic fashion. Specifically, any bending of the spring may cause the spring to impact against the inner glass surface of the cartridge and cause breakage thereof. In addition, the mere compression of medicament within the glass cartridge during compressive expulsion of such medicament with the plunger may be sufficient to cause breakage of the cartridge if proper precautions are not taken. While the above-mentioned scenarios are extremely infrequent and unlikely, it can be appreciated that the emergency use of these injectors requires that such scenarios be limited to the fullest extent feasible.
Aside from breakage, two other problems exist with glass cartridges. First, they are relatively expensive to manufacture, and second, they are very difficult to manufacture with close tolerances.
Thus, there is a need for an automatic injector which has a cartridge made from a substance which is more durable, workable and/or less expensive than glass. In at least one instance metal has been used. Specifically, an automatic injector having a stainless steel cartridge is manufactured by the assignee of the present invention and sold under the registered trademark ATROPEN®. While it has also been determined that plastic might be another viable alternative, it has heretofore not been widely practical as will be discussed later.
Metal and plastic both have several advantages over glass in that it can be made both thinner and lighter while at the same time stronger than glass. Thus, the automatic injector can become more durable and more reliable. However, several problems exist with providing such metal and plastic cartridges. First, metal cartridges may react with certain (if not all) medicaments (for example, lidocaine) and thereby contaminate such medicaments. With respect to plastic, a problem exists in that plastic is not completely impervious to moisture and oxygen, and therefore not well suited to store a medicament for extended periods. Thus, while it may also be desirable to use plastic in the main body of a prefilled conventional syringe (in addition to use in automatic injectors), such use has also been rather impractical for many types of medicines.
Another problem with metal, plastic, and even glass syringe and autoinjector medicament containers, is that a plunger provided therein for expelling medicament therefrom has a tendency to adhere to the side walls thereof during extended periods of non-use. For example, it has been known that a resilient plunger sitting in contact with a metallic cartridge for a significant period of time may eventually become slightly adhered to the metallic surface of the cartridge. At the same time, it has been found that the stressed spring contained within an auto-injector weakens in strength after remaining in compression for extended periods. As a result, when the auto-injector is eventually actuated, there is a possibility that the speed with which the plunger travels through the cartridge will be reduced as a result of the friction and adhesion between the plunger and cartridge. Thus, the medicament may not be dispensed at all or will be dispensed more slowly than what might otherwise be possible. This is significant since the time interval which lapses before a full dosage of medicament is dispensed may be important to the remedial results which are obtained by administration of the medicament.
It is therefore an object of the present invention to solve the problems mentioned above. These problems can be remedied by providing an automatic injector having a metallic cartridge coated by an appropriate substance. While it has been known to treat glass and other type cartridges with silicone oil or emulsion, to reduce the coefficient of friction of the sliding plunger, such silicone is undesirable. Silicone, ideally, should not be injected into a patient. In addition, such silicone does not adequately prevent metal from reacting with the medicament contained in the cartridge. Moreover, while silicone can be effectively baked onto the surface of glass vials or cartridges at high temperature, it has been found that silicone is more difficult to adhere to metal to provide the same lubricating effect. Therefore, to solve these problems, the present invention contemplates providing a metallic cartridge having a polyparaxylylene coating applied to at least an inner surface thereof. When such coating is applied to metal, medicament contamination is prevented, the injector is less subject to breakage than if glass were used as a container, is more reliable and efficient in plunger operation, and is less expensive to manufacture with tighter tolerances.
Polyparaxylylene has been found to be useful in coating various materials. For example, in Romberg et al, U.S. Patent No. 5,000,994 it is disclosed that it is useful to coat rubber closures in order to reduce ion extraction from the rubber material into the medicament and to reduce the coefficient of friction of the surface of such rubber closures to facilitate the manufacture thereof as such rubber components may become hung up on one another or on transfer equipment. This disclosure is not concerned with using polyparaxylylene to coat a non-glass container to provide a more economic, reliable, and durable container. It should also be noted that it has been found that application of polyparaxylylene to the plunger in an automatic injector may harden the elastic surface of the plunger and may have a detrimental effect on the seal between the plunger and cartridge.
Romberg et al, U.S. Patent No. 4,882,210, on the other hand, discloses the use of polyparaxylylene for coating a glass container in order to prevent ion extraction from the glass and increase the crush strength of the glass. The disclosure addresses the fact that during assembly with a rubber stopper, glass vials are subject to breakage. The patent suggests that providing a polyparaxylylene coating to at least one side of a glass container can increase the strength of such glass container. However, this patent fails to appreciate that polyparaxylylene can effectively be used to coat other substances, such as metal, to not only obtain compatibility of such materials with medicaments, but also allows use of other materials to effectively increase the strength of a container by several orders of magnitude over that of glass.
None of the above-mentioned references contemplates coating a metallic container for medicaments, as glass has long been the material of choice for containing medicaments. Moreover, no one has ever suggested the use of such coated container for the specialized application in automatic injectors. In addition, none of the art has attempted to utilize polyparaxylylene to coat a metallic injector cartridge so that it can more easily cooperate with a plunger to more speedily and reliably dispense a medicament from a medicament cartridges. This may be due to the fact that the art related to polyparaxylylene has heretofore not concerned itself with the need to carry medicaments into harsh environments such as those environments into which an automatic injector must be taken.
Therefore, it is an object of the present invention to provide an automatic injector comprising a housing having a metallic cartridge contained therein. The cartridge has at least an inner surface thereof provided with a polyparaxylylene coating. A charge of medicament is contained within the metallic cartridge and in communication with the polyparaxylylene coating, which reduces the coefficient of friction of the inner surface of the cartridge and prevents metallic ions from being extracted from the cartridge and into the medicament. A plunger is normally disposed in a generally rearward end of the metallic cartridge, and is movable through the cartridge toward a generally forward end thereof in response to a predetermined actuating procedure. The movable plunger rearwardly confines the medicament within the metallic cartridge and is in slidable sealed relation with the polyparaxylylene coating provided on the metallic cartridge. The polyparaxylylene coating reduces the tendency of the plunger to adhere to the inner surface and reduces the time required for the plunger to travel from the generally rearward end to the generally forward end of the metallic cartridge. A needle is normally disposed within the housing and is projectable from a forward end of the housing and communicable with the medicament so that movement of the plunger through the cartridge forces the medicament through the needle and into the tissue of a user in response to the predetermined actuating procedure. In addition, a releasable energy source is releasable in response to the predetermined actuating procedure to project the needle and slidingly drive the plunger through the metallic sealed relation to expel the medicament through the needle and into the tissue of the user.
In another aspect of the present invention, it can be appreciated that certain of the aforementioned automatic injectors are provided with a metallic needle that is normally stored in contact with a medicament. Such type of injectors are disclosed in our previously granted U.S. Patent Nos. 4,484,910, 5,085,642, and 5,092,843. An advantage of such injectors is that they have a shorter axial length than other type of injectors that have the needle normally stored in a separately provided chamber disposed forwardly of the medicament (e.g. see our previously granted U.S. Patent No. 5,102,393). As stated previously, metal cartridges may react with certain medicaments, such as lidocaine, and thereby contaminate such medicaments. To solve the problem associated with such contamination, it is a further object of the present invention to provide an automatic injector which comprises a housing, a cartridge contained within the housing, a charge of medicament contained in the cartridge, and a needle normally disposed within the cartridge so as to be in communication with the medicament. The needle is provided with a polyparaxylylene coating for preventing ions from being extracted from the needle into the medicament. The needle is projectable from a forward end of the housing, while a plunger is normally disposed in a generally rearward end of the cartridge and movable through the cartridge in response to a predetermined actuating procedure so as to force the medicament through the needle and into the flesh of an individual. In addition, a releasable energy source is releasable in response to the predetermined actuating procedure to project the needle from the forward end of the housing and drive the plunger through the cartridge to expel the medicament through the needle and into the flesh of the individual.
US-A-4,225,647 discloses the vapour phase coating of polyparaxylylene on surfaces of various objects which are quite different from the surface and object which are coated with polyparaxylylene with accordance with the disclosure and claims of the present invention.
SUMMARY OF THE INVENTION
The invention relates to an automatic injector as claimed in claims 1 and 10.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a longitudinal sectional view, with a portion thereof shown enlarged, of an automatic injector embodying the principles of the present invention.
DETAILED DESCRIPTION OF THE DRAWINGS
An automatic injector, generally indicated at 10 embodies the principles of the present invention. The injector 10 includes a tubular housing 12, a medicament injecting assembly, generally indicated at 14, within the forward end portion of the housing assembly 12, and a releasable energy source which is releasable in response to a predetermined actuating procedure as will be described more fully later. While the releasable energy source can be any type of assembly which effectuates an injection operation (e.g. a compressed gas assembly as disclosed in our U.S. Patent No. 4,518,384), it is preferred that the releasable energy source be a stressed spring assembly, as generally indicated at 16. The stressed spring assembly is disposed within the rearward end portion of the housing assembly 12 in operative relation with the medicament injecting assembly 14. A releasable end safety cap 18 positioned at the rear of the housing assembly 12 is in operative relation with the stressed spring assembly 16.
The housing assembly 12, medicament injecting assembly 14, and stress spring assembly 16 are generally constructed in accordance with the teachings of U.S. Patent No. 2,832,339. As shown in FIGURE 1, the housing assembly includes a cylindrical outer housing member 20 having a centrally apertured cylindrical rear wall portion 22 of reduced diameter on which the safety end cap 18 is mounted. The housing assembly 12 also includes an inner cylindrical housing member 24 within the housing member 20 within which is mounted the medicament injecting assembly 14 and the stressed spring assembly 16. The forward portion of the inner housing member 24 is formed with a counterbore for receiving therein a cylindrical dosage container or cartridge 26. This cartridge is made of a metallic material. The preferred metallic materials are stainless steel and aluminium. Cartridge 26 has an inner surface 27 which is coated with a continuous poly (p-xylylene) or polyparaxylylene coating 29 (see, exploded portion of FIGURE 1).
This coating is preferably provided to the cartridge or container by a process in which the polymer is deposited onto the cartridge from the vapor phase in a manner which resembles vacuum metallization. Unlike vacuum metallization, however, which is conducted at pressures of 10-5 torr or below, the polyparaxylylene coating is formed at around 0.1 torr. Such coating is also known as Parylene and is provided by Specialty Coating Systems, Inc. of Indianapolis, IN. As a result of the procedure in which the polyparaxylylene is applied to the cartridge 26, it can be appreciated that the outer surface of the cartridge may also be coated. However, steps could be taken to prevent the coating of the outer surface if so desired.
It has been found that Polyparaxylylene has several useful properties, such as low permeability to oxygen and moisture, low coefficient of friction, high durability at high temperatures (expected lifetime of approximately ten years at 100 degrees Celsius), high resistance to impact at cryogenic temperatures, high chemical resistance, and excellent adhesion to the surface it is provided to.
In the broadest sense, the polyparaxylylene should have a thickness of between about 0,00025 mm to 0.0025 mm (.00001 to .001 inches). In the case of metal the coating preferably ranges from 0.0013 mm to 0.0076 mm (.00005 to .0003 inches), and in the case of plastic, it is preferred that the coating range from 0,0017 mm to 0,013 mm (.00007 to .0005 inches) in thickness. The polyparaxylylene coating in the present invention has a preferred thickness ranging between a minimal level of acceptable intended functionality and a maximum level beyond which any added functionality which might be obtained from additional thickness is not worth the added cost of material required to obtain such increased thickness.
The forward end of the container or cartridge 26 is closed by a stopper or plug 28 of suitable rubber or plastic material. Plug 28 is retained in closing relation with the forward end of the cartridge 26 by a housing end cap member 30 of molded plastic material. The cap is retained on the inner housing member 24 by inter-engagement of a pair of ridges 32 formed on the exterior periphery of the tubular member 24 with an annular groove 34 formed on the interior periphery of the cap member 30. The rearward end of the cartridge 26 is closed by a plunger 36 which is slidably, sealingly engaged with the polyparaxylylene coating 29 at the rearward end of the cartridge so as to enclose within the cartridge a dosage 38 of a liquid medicament. The polyparaxylylene coating 29 reduces the coefficient of friction of the inner surface 27 of the cartridge 26 and eases movement of the plunger when the plunger is forced forwardly through cartridge 26 (towards the right in FIGURE 1). Preferably, plunger 36 is coated with a substance which prevents extraction of metallic ions therefrom into the medicament 38 and further helps the plunger move through cartridge 26 during an injection. Such coating must be made of a material which is medicament compatible. While the coating can be polyparaxylylene, it is preferably made of some other medicament compatible substance as it has been found that polyparaxylylene may harden the outer surface of the elastic plunger to the extent that the plunger is unable to make an effective seal with the cartridge.
A hypodermic needle 40 is disposed within the cartridge 26. As can be discerned from Figure 1, needle 40 is normally stored in contact with the medicament 38. However, in the broadest aspects of the present invention, it can be appreciated that needle 40 can be disposed in a separate chamber (either evacuated or filled with a preferably inert gas) forwardly of the medicament 38 (for example, see our U.S. Patents No. 5,085,642 and 5,102,393), so long as the needle is somehow communicable with the medicament in a manner which permits the medicament to travel through the needle and into the flesh of an individual. The needle can also be disposed in contact with one of two medicaments, which are normally stored separately within the injector and then either mixed within the injector prior to an injection (e.g. see U.S. Patent No. 5,041,088) or injected separately one after the other (see U.S. Patent No. 5,092,843).
The hypodermic needle 40 is preferably made from stainless steel. In the instance in which the needle is stored in contact with the medicament, as described above, it is preferred that the needle be coated with a layer of polyparaxylylene to prevent ions from being extracted from the needle and into the medicament. Both the external surface of the needle (visible in Figure 1) and the internal surface (defining the inner path through the needle) can be coated.
The needle 40 has its pointed end disposed within a recess formed in the plug 28. A disc 42 of plastic is disposed within the forward end of the cartridge 26 in surrounding sealed relation with the hypodermic needle 40 and in abutting engagement with the plug 28. The disc serves to releasably hold the needle in its storage position to provide peripheral centering therefor during the dosage injecting stroke of the plunger 36. The rearward end of the hypodermic needle 40 is enlarged for engagement by the plunger and has a slot 44 formed in its periphery adjacent the enlarged end for communicating the dosage 38 with the hollow interior of the hypodermic needle 40 when the plunger 36 is in engagement therewith. The inner housing member 24 is mounted within the outer housing member 20 for limited reciprocating movement as determined by a pair of ridges 46 formed on the exterior periphery of the tubular inner housing member 24 at a position spaced rearwardly from the pair of ridges 32. The pair of ridges 46 is adapted to engage with an elongated annular groove 48 formed on the interior periphery of the outer housing member 20.
The stressed spring assembly 16 includes a normally compressed but releasable coil spring 52 and an elongated collet member 50 made up of two interfitted stampings. The collet member is disposed within the rearward portion of the housing member 24 and has its forward end disposed in abutment with the plunger 36. The forward end of the collet member 50 is also exteriorly configured to engage the forward end of the stressed coil spring 52 which surrounds the central portion of the elongated collet member 50 within the inner housing member 24 and has its rearward end engaged with an apertured end wall formed integrally on the rearward end of the inner housing member 24.
The rearward ends of the stampings of the elongated collet member 50 are split to provide four laterally movable spring fingers 56, the rearward extremities of which are formed with rearwardly and outwardly facing cam releasing surfaces 58.
Extending inwardly from the forward end of each cam surface 58 is a locking shoulder 60 adapted to engage a locking ring 62 seated on the rear surface of the centrally apertured rear wall 54. The forward portion of the apertured cylindrical wall portion 22 is formed with a frusto-conical surface 64 which is disposed in engagement with the cam surfaces 58 so as to effect a laterally inward movement of the spring fingers toward one another to disengage locking shoulders 60 from locking ring 62 in response to a relative forward actuating movement of the outer housing member 20 with respect to the inner housing member 24.
The operation of the injector will now be described. In the first step of operation, releasable end cap 18 is removed from the injector 10. This removal is accomplished simply by gripping the exterior periphery of the end cap 18 and moving it rearwardly while gripping and holding the outer housing member 20. The removal of the cap member 18 carries with it a safety pin portion 70. With the safety pin portion 70 removed from its safety position which normally prevents the laterally inward movement of the spring fingers 56, the user can now complete the operation by moving the forward cap member 30 into contact with the tissue of a person to be injected. By applying a continued forward force on the exterior periphery of the outer housing member 20, cam surfaces 64 thereof are moved forwardly with respect to the locking ring 62. This forward movement in cooperation with the cam surfaces 58 on the spring fingers 56 causes the locking surfaces 60 of the latter to move laterally inwardly of the locking ring 62 thus releasing the stressed spring 52. The spring 52 acts through the collet member 50 to move the same forwardly which has the effect of moving the plunger 36 with it. As the plunger moves forwardly, it carries with it the needle 40. The pointed forward end of the needle pierces through the plug 28 and into the muscle tissue of the patient. At the same time, the dosage 38 of liquid medicament within the cartridge 26 is caused to move inwardly into the slot 44 of the needle and outwardly of the pointed forward end thereof as the same moves into the muscle tissue of the user. After the forward movement of the plunger has been completed, the user simply withdraws the needle 40 rearwardly.
As a result of the provision of the polyparaxylylene coating to the injector cartridge, the durability, operation, reliability, and medicament compatibility are greatly improved as previously described.
For purposes of background and elaboration of the present disclosure, the disclosures of the patents mentioned herein are incorporated by reference into the present specification.
It thus will be seen that the objects of this invention have been fully and effectively accomplished. It will be realized, however, that the foregoing preferred specific embodiment has been shown and described for the purpose of illustrating the functional and structural principles of this invention, and is subject to change without departure from such principles. Therefore, this invention includes all modifications encompassed within the scope of the following claims.

Claims (11)

  1. An automatic injector comprising:
    a housing (12);
    a cartridge (26) contained with said housing (12);
    a charge of medicament (38) contained in said cartridge (26);
    a plunger (36) normally disposed in a generally rearward end of said cartridge (26) and movable through said cartridge (26) toward a generally forward end thereof in response to a predetermined actuating procedure, said plunger (36) rearwardly confining said medicament (38) within said cartridge (26) and;
    a needle (40) normally disposed within said housing (12), said needle (40) being projectable from a forward end of said housing (12) and communicable with said medicament (38) so that movement of said plunger (36) through said cartridge (26) forces said medicament (38) through said needle (40) and into the flesh of an individual in response to said predetermined actuating procedure; and
    a releasable energy source releasable in response to said predetermined actuating procedure to project said needle (40) from the forward end of the housing (12) and slidingly drive said plunger (36) through said cartridge (26) in sealed relation to expel said medicament (38) through said needle (40) and into the flesh of an individual,
       characterized by said cartridge (26) made from a metallic material and having at least an inner surface (27) thereof coated with polyparaxylylene (29) to reduce the coefficient of friction of said inner surface (27), said medicament (38) in communication with said polyparaxylylene coating (29), said polyparaxylylene coating (29) preventing ions from being extracted from said metallic cartridge (26) into said medicament (38), said plunger (36) being in slidable sealed relation with said polyparaxylylene coating (29) provided on said metallic cartridge (26), said polyparaxylylene coating (29) constituting a lubricating surface for facilitating movement of said plunger (36) from said generally rearward end to said generally forward end of said metallic cartridge (26).
  2. The automatic injector as claimed in claim 1, wherein said metallic material is made from stainless steel.
  3. The automatic injector as claimed in claim 1, wherein said metallic material is made from aluminum.
  4. The automatic injector as claimed in claim 1, wherein said polyparaxylylene coating (29) has a thickness between about 0.00025 to 0.025 mm (.00001 to .001 inches).
  5. The automatic injector as claimed in claim 4, wherein said polyparaxylylene coating (29) has a thickness between about 0.00127 to 0.0762 mm (.00005 to .003 inches).
  6. The automatic injector as claimed in claim 1, wherein said needle (40) is stored in contact with said medicament (38).
  7. The automatic injector as claimed in claim 6, wherein said needle (40) is provided with a coating of polyparaxylylene.
  8. The automatic injector as claimed in claim 1, wherein said releasable energy source comprises a normally compressed spring (16) which is decompressed in response to said predetermined actuating procedure.
  9. The automatic injector according to claim 1, wherein said polyparaxylylene coating (29) constituting said lubricating surface reduces the time required for the plunger (36) to travel from said generally rearward end to said generally forward end of said metallic cartridge.
  10. An automatic injector comprising:
    a housing (12);
    a cartridge (26) contained within said housing (12);
    a charge of medicament (38) contained in said cartridge (26);
    a needle (40) normally disposed within said cartridge (26) so as to be in communication with said medicament (38), said needle being projectable from a forward end of said housing (12);
    a plunger (36) normally disposed in a generally rearward end of said cartridge (26) and movable through said cartridge (26) in response to a predetermined actuating procedure so as to force said medicament (38) through said needle (40) and into the flesh of an individual; and
    a releasable energy source which is releasable in response to said predetermined actuating procedure to project said needle (40) from the forward end of the housing and drive said plunger (36) through said cartridge (26) to expel said medicament (38) through said needle (40) and into the flesh of an individual,
       characterized by said needle (40) being made from a metal material and being provided with a polyparaxylylene coating for preventing ions from being extracted from said needle (40) into said medicament (38).
  11. The automatic injector as claimed in claim 10, wherein said releasable energy source comprises a normally compressed spring (16) which is decompressed in response to said predetermined actuating procedure.
EP95904071A 1993-12-07 1994-11-22 Injection device having polyparaxylylene coated container and needle Expired - Lifetime EP0732950B1 (en)

Applications Claiming Priority (3)

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US162294 1980-06-23
US08/162,294 US5354286A (en) 1993-12-07 1993-12-07 Injection device having polyparaxylylene coated container
PCT/US1994/013196 WO1995015777A1 (en) 1993-12-07 1994-11-22 Injection device having polyparaxylylene coated container

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EP0732950A1 EP0732950A1 (en) 1996-09-25
EP0732950A4 EP0732950A4 (en) 1997-06-18
EP0732950B1 true EP0732950B1 (en) 2002-03-20

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EP (1) EP0732950B1 (en)
AU (1) AU1289495A (en)
DE (1) DE69430210T2 (en)
IL (1) IL111900A (en)
WO (1) WO1995015777A1 (en)

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AU1289495A (en) 1995-06-27
WO1995015777A1 (en) 1995-06-15
DE69430210T2 (en) 2002-10-10
EP0732950A4 (en) 1997-06-18
US5354286A (en) 1994-10-11
EP0732950A1 (en) 1996-09-25
IL111900A (en) 1997-07-13
IL111900A0 (en) 1995-03-15
DE69430210D1 (en) 2002-04-25

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